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临床试验/CTRI/2025/12/098723
CTRI/2025/12/098723尚未招募不适用

Impact of arithmetic and reading comprehension exercises on the cognitive abilities of healthy elderly people

未提供1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
We hypothesize that consistent practice of arithmetic and reading

研究概览

简要总结

1. Title of the study: Impact of Arithmetic and Reading Comprehension Exercises on

Cognitive Abilities of Healthy Elderly People

2. Introduction (Background and Justification):

·        ‘Cognitive functions” refers to includes attention, memory, language, orientation, praxis, executive functions, judgement, and problem-solving. (Deary et al., 2009).

·         The functions of processing speed, memory, reasoning, and executive functions are called fluid mental abilities, and they are known to reduce with age (Harada, Natelson Love, & Triebel, 2013).

·        Cognitive stimulation is listed as an important preventive factor for Dementia by the 2024 report of the Lancet standing commission (Livingston G.,2024).

·         Brain training games like simple arithmetic and reading aloud improved executive function and processing speed in elderly Japanese volunteers (Nouchi et. al (2012)

·        Reading and arithmetic in particular have been shown to improve cognition in the long-term and protect against cognitive decline and development of Alzheimer’s disease (Chang,Y.H.,2021, Smith,G.E.,2009, Singh,P.,2016).

·        Longitudinal studies of brain exercise and cognitive health are currently limited within the literature. Additionally, many studies have tested computer-based training activities, but have not assessed the efficacy of activities on paper, which may be more accessible for certain populations. Finally, studies about the cognitive health of elderly Indian adults are limited.

Aim:

The aim of this study is to understand the potential for brain exercises, specifically

arithmetic and reading, to improve the cognitive abilities of healthy elderly individuals

in the Indian population.

Objective:

 To assess the impact of arithmetic and reading comprehension exercises on cognitive

abilities on the PGI Memory scale

Hypothesis: We hypothesize that consistent practice of arithmetic and reading

exercises over several weeks will improve performance on neuropsychological

assessments.

3. Methodology:

Subjects: The study will be performed on 20 healthy elderly people in the community attending walker’s clubs or senior citizens organizations. The members of the organizations will be informed about the study through their respective groups online or offline in their group meetings and interested participants will be recruited after obtaining written informed consent.

Sample size: 20

Inclusion criteria:

·       Age above 60 years

·       Speaking, reading English

·       Hindi Mental Status Examination (HMSE) score >/=29

·       Education: Diploma or equivalent and graduation

·       Providing written informed consent

·       Functional Assessment Staging Test (FAST) stage 1or 2

Exclusion Criteria:

·       HMSE score < 29

·       FAST stage >2

·       Inability to provide informed consent

·       H/o Severe psychiatric illness

·       History of CVA

·       H/o Uncontrolled Hypertension/ Diabetes

·       History of TBI

·       Medications known to impair cognitive functions

·       Diagnosed case of MCI/Dementia

Study Design: Open-label interventional study

Sample Size : 20

Instruments:

Participant Data Sheet

Hindi Mental Status Examination:

Hindi mental status examination (Ganguly & Ratcliff, 1994). It was prepared in 1995 by Ganguly et al. It is an adapted version of the Mini Mental Status Examination test developed by Folstein. It has items modified from MMSE: Orientation to time in closed sentences, place as per terms used here, task to assess attention is days of week backward instead of spelling WORLD/100-7, sentence for repetition, reading face rather than read instructions, telling a sentence instead of writing a sentence, copying diamond inside a square instead of pentagons, difference in 3 object recall. It measures cognitive functions that are impaired in dementia. It was validated in the Ballabgarh district in India and is widely used all over the world.

PGI memory scale (Pershad et al.,1978):

Tests of attention, working memory, visuospatial processing,Arithmetic and Reading Comprehension Exercises. It is a reliable test and a valid test to assess memory in elderly people (Pershad et al.,1978).

4.Procedure:

Participants will be assigned brain exercises once a day for three weeks. These include 45 simple arithmetic exercises (addition, subtraction, multiplication, and division), and one 700-1500 word reading passage on various subjects, including but not limited to history, science, and lifestyle. Each reading passage will be accompanied by 5 comprehension questions related to basic facts presented within the reading passages. Sessions may be conducted online or offline based on comfort of the participants as a group. In case of online session, link will be provided to the interested participants. In the case that participants have visual or auditory deficits, materials will be adapted to ensure participants can complete both the arithmetic and reading activities. Materials will be developed by experimenters daily.

After three weeks, participants will take a second HMSE and PGI memory scale assessment.

4.Data Management and Statistical Plan:  Data will be collected and stored in a confidential manner. Statistical analysis will be performed with a t-test to compare baseline and final scores on the HMSE and PGI-memory scale. Additionally, a repeated measures ANOVA will be performed to analyze differences between the two groups after 6 months to negative the influence of practice-effect.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
60.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age above 60 years and should be able to speak and read English with a Hindi Mental Status Examination (HMSE) score more than or equal to 29 years and with an educational background of Diploma or equivalent, and graduation and should be able to provide a written informed consent and have a Functional Assessment Staging Test (FAST) stage 1 or 2.

排除标准

  • HMSE score less than 29 with a FAST stage greater than 2 with an inability to provide informed consent, suffering from a history of Severe psychiatric illness and recent history of cerebrovascular accident.

结局指标

主要结局

We hypothesize that consistent practice of arithmetic and reading

时间窗: Assessment with PGI memory scale will be performed at the baseline and following intervention, at 3 weeks.

exercises over several weeks will improve performance on neuropsychological

时间窗: Assessment with PGI memory scale will be performed at the baseline and following intervention, at 3 weeks.

assessments on PGI memory scale

时间窗: Assessment with PGI memory scale will be performed at the baseline and following intervention, at 3 weeks.

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr. Sravani Gaddipati

Gayatri Vidya Parishad Institute of Health Care and Medical Technology

研究点 (1)

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